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A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients - CA127-1026

Updated: 19 July, 2023   |

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1


  • Gender(s)

  • 18+

    Age Range

  • 2


  • Recruiting

Treatment Options

Study Arms
Experimental: Repotrectinib (TPX-0005)
Drug: repotrectinib (TPX-0005)

Key Eligibility Criteria

Key Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor for which standard curative or palliative measures do not exist or are no longer effective. In case of hepatocellular carcinoma, the diagnosis should be based on at least 1 of the following: 1. The presence of at least 1 lesion, measuring ≥2 cm, with characteristic arterial enhancement and venous washout in the setting of liver cirrhosis and/or hepatitis B or C infection. 2. The presence of liver lesion(s) (as defined in inclusion criteria 3a) with alphafetoprotein ≥ 400 ng/mL. 3. Tissue confirmation. 2. For patients with genetic ROS1 or NTRK 1-3 gene fusion, tissue-based local testing should be documented. 3. Biliary obstruction for whom a biliary drain or stent has been placed are eligible. 4. Eastern Cooperative Oncology Group Performance Status scores 0 to 2. 5. The patient must have no clinically significant change in hepatic disease status within the last 30 days before screening. 6. Patient with ascites must not have a paracentesis within 3 months of screening. 7. Protocol specified baseline hematology and kidney function laboratory values Key Exclusion Criteria: 1. Concurrent participation in another therapeutic clinical study. 2. Symptomatic brain metastases or leptomeningeal involvement. 3. Major surgery within 4 weeks. 4. Clinically significant cardiovascular disease. 5. History of non-pharmacologically induced prolonged QT interval corrected for heart rate interval. 6. Known active infections requiring ongoing treatment (bacterial, fungal, or viral, including human immunodeficiency virus positivity). 7. Gastrointestinal disease or other malabsorption syndromes. 8. Current use or anticipated need for drugs that are known to be strong cytochrome P450 (CYP) 3A inhibitors or inducers.

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Side Effects (Adverse Events) and other reportable events are defined here
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